Reportable events (new information, unanticipated problems, noncompliance) that occur at any site for which UW-Madison is serving as the reviewing IRB must be reported to the UW-Madison IRBs pursuant to UW-Madison requirements. You as the lead study team are responsible for obtaining relevant information from relying sites and submitting information to the UW-Madison IRBs for review.

• Once you learn of a reportable event at a relying site, gather the information needed to submit the reportable event to the UW-Madison IRB within the appropriate timeframe.
  • To gather information from the relying site(s) where the event occurred, communicate with the relying site study team. You can use HRP-214 – FORM – Reportable New Information to aid in your communication about the event. This form requests the information that is needed to complete the reportable event form in ARROW.
  • If you are using HRP-214 as a tool to collect information from the relying site, fully completing the form is NOT a prerequisite for submitting a reportable event and the form does not need to be submitted in the RE. The reportable event should be submitted as soon as the reportable event form can be accurately completed (see the reportable event link above for reporting timelines).
  • For the protocol-based and non-protocol-based applications, you will use the same process for submitting a reportable event for a relying site as other reportable events.
  • For the sIRB application, any event that meets UW IRB reporting criteria that occurs at a participating site (including UW-Madison), should be submitted as a reportable event in the main study workspace.